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Experience Level
Experience
Qualifications
We are looking for candidates with a robust background in pharmacovigilance or drug safety, ideally with a Master’s degree or higher in a relevant field. A minimum of 5 years of experience in the pharmaceutical industry is required, with a strong emphasis on regulatory compliance and reporting. You should possess excellent analytical skills, attention to detail, and the ability to work collaboratively in a fast-paced environment.
About the job
As the Associate Director of Pharmacovigilance, you will play a crucial role in ensuring the safety and efficacy of our pharmaceutical products. You will lead a team dedicated to monitoring and evaluating adverse drug reactions, while also collaborating closely with regulatory bodies to uphold our commitment to patient safety. Your expertise will contribute significantly to our ongoing efforts in drug development and post-marketing surveillance. Join us in making a difference in the lives of patients around the world.
About Deciphera Pharmaceuticals, Inc.
Deciphera Pharmaceuticals, Inc. is at the forefront of transforming the treatment landscape for patients with cancer. We focus on developing innovative therapies that target the underlying mechanisms of disease. Our commitment to scientific excellence and patient safety drives our work, and we are seeking passionate individuals to join our mission.
Join AbbVie as an Associate Director in Regulatory Affairs with a focus on Chemistry, Manufacturing, and Controls (CMC). In this pivotal role, you will lead cross-functional teams to ensure compliance with regulatory requirements while advancing our innovative therapies. As a leader, you will drive the development of CMC submission strategies, collaborate wi…
We are seeking a skilled and experienced CMC Regulatory Affairs Manager to join our dynamic team. In this pivotal role, you will oversee the regulatory strategy and submissions related to Chemistry, Manufacturing, and Controls (CMC) for our biopharmaceutical products. Your expertise will ensure compliance with regulatory requirements and support the successful development of our innovative therapies.
Full-time|$213K/yr - $286K/yr|Hybrid|Waltham, Massachusetts, United States
Join Our Mission:Oruka Therapeutics (Nasdaq: ORKA) is at the forefront of developing cutting-edge biologics aimed at revolutionizing the treatment of chronic skin diseases. Our commitment is to provide patients afflicted by conditions such as plaque psoriasis with unprecedented freedom by achieving significant disease clearance with infrequent dosing—sometimes as little as once or twice a year. We are advancing a proprietary pipeline of potentially best-in-class antibodies that target the fundamental mechanisms of plaque psoriasis and other dermatological and inflammatory ailments. Discover more about us at www.orukatx.com.As we expand our core team, we are looking for exceptional individuals who are not just seeking employment but are passionate about contributing to a broader cause. We value candidates who are eager to foster an inclusive and dynamic company culture.Position Overview:We are in search of a seasoned and motivated leader in regulatory CMC to shape our strategy and execution across various stages of biologics programs. In this role, you will be responsible for the development of high-quality regulatory CMC submissions and will provide guidance to cross-functional teams on global regulatory expectations appropriate for different phases. Ideal candidates will bring extensive expertise in biologics development and manufacturing, particularly in drug substance and product CMC submissions. You will play a crucial role in influencing program strategies, facilitating collaboration across CMC, QA, RA, Supply Chain, and external partners, and driving pivotal decisions that support our expanding biologics pipeline. This highly visible role involves ensuring compliance with FDA, EMA, ICH, and WHO guidelines while meeting corporate and program-level objectives.
Full-time|$213K/yr - $286K/yr|Hybrid|Menlo Park, California, United States; Remote; Waltham, Massachusetts, United States
About Oruka Therapeutics Oruka Therapeutics (Nasdaq: ORKA) develops biologics for chronic skin conditions, with a focus on achieving strong disease clearance through infrequent dosing, sometimes as little as once or twice per year. The company’s pipeline includes antibodies engineered by Paragon Therapeutics that target the underlying mechanisms of plaque psoriasis and other dermatological and inflammatory diseases. Learn more at www.orukatx.com. Role Overview Title: Director / Senior Director, Regulatory Affairs Strategy Location: Hybrid preferred (Menlo Park, CA or Waltham, MA). Remote considered. This position serves as Global Regulatory Lead for one or more development programs and reports directly to the Vice President of Regulatory Affairs. The Director/Senior Director will define and execute regulatory strategies to support the global advancement of Oruka’s biologics, with a focus on immunology and dermatology programs. What You Will Do Lead regulatory strategy for assigned programs, translating product goals into actionable development and registration plans. Drive key regulatory milestones and oversee major submissions. Represent Oruka in interactions with health authorities. Identify regulatory risks and opportunities in alignment with company objectives. Collaborate across functions to ensure high-quality, timely global development of the portfolio. What Sets This Role Apart This is a visible leadership role with influence over the regulatory direction of programs aiming for infrequent dosing, strong efficacy, and lasting results in psoriasis and related conditions. The position offers the chance to shape strategies for a pipeline of engineered antibodies intended to change how chronic skin diseases are treated.
Full-time|$218.4K/yr - $273K/yr|On-site|Waltham, MA
Zenas Bio is at the forefront of biopharmaceutical innovation, dedicated to transforming the lives of patients with autoimmune diseases through the development and commercialization of groundbreaking therapies. Our strategic approach leverages a seasoned leadership team and a meticulous product acquisition strategy to identify, acquire, and develop promising therapies worldwide. We are currently advancing two late-stage candidates: obexelimab and orelabrutinib. Obexelimab, our leading candidate, is a unique bifunctional monoclonal antibody targeting both CD19 and FcγRIIb to inhibit the pathological activity of B cells involved in autoimmune diseases, while preserving their presence. This innovative therapy is designed for self-administration via subcutaneous injection, offering a potentially effective solution for chronic autoimmune conditions. Meanwhile, orelabrutinib is a highly selective, oral Bruton’s Tyrosine Kinase (BTK) inhibitor with the potential to manage compartmentalized inflammation in Multiple Sclerosis (MS). Our earlier-stage pipeline includes a preclinical, oral IL-17AA/AF inhibitor and a brain-penetrant TYK2 inhibitor, both of which hold promise for advancing patient care.We are on the lookout for exceptional talent who share our passion for patient care and have a proven record in product development and commercialization on a global scale. At Zenas, you will thrive in a dynamic learning environment, contributing to our mission of becoming a global leader in immunology and autoimmune disease treatment while embodying our core values of Transparency, Relationships, Urgency, Excellence, and Innovation – TRUE Innovation!Position Summary:The Senior Director of Regulatory Affairs (RA) will act as the Global Regulatory Lead for a multi-indication late-phase investigational product, overseeing global regulatory submissions in the US and EU, and contributing to the advancement of Phase 2 indications through clinical development planning. This role will also involve managing regulatory strategies for at least one early-phase investigational product, including the preparation and submission of IND/CTA/amendments and future marketing applications. The Senior Director will provide strategic guidance on regulatory submissions, responses, and essential regulatory intelligence, while collaborating with a diverse cross-functional team and key internal and external stakeholders.
Zenas Bio is a pioneering clinical-stage global biopharmaceutical organization dedicated to becoming a frontrunner in the development and commercialization of groundbreaking therapies for patients suffering from autoimmune diseases. Our strategic vision combines an accomplished leadership team with a meticulous approach to product candidate acquisition, enabling us to identify, acquire, and develop innovative products worldwide that offer significant clinical benefits to patients living with autoimmune conditions. Zenas is advancing two late-stage potential franchise molecules: obexelimab and orelabrutinib. Obexelimab, our flagship product candidate, is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, prevalent across B cell lineages, to inhibit the activity of cells implicated in various autoimmune diseases without depleting them. We are confident that obexelimab’s unique mechanism of action and its self-administered, subcutaneous injection regimen can effectively address the pathogenic role of B cell lineages in chronic autoimmune diseases. Orelabrutinib represents a potentially best-in-class, highly selective CNS-penetrant, oral small molecule Bruton’s Tyrosine Kinase (BTK) inhibitor, promising to tackle compartmentalized inflammation and disease progression in Multiple Sclerosis (MS). Our earlier-stage programs also include a preclinical, potentially best-in-class, oral IL-17AA/AF inhibitor and a preclinical, brain-penetrant, oral TYK2 inhibitor.We are on the lookout for exceptional talent who share our dedication to patients and possess a proven track record in acquiring, developing, and commercializing products on a global scale. Our team members enjoy a dynamic learning environment where they can achieve both individual and organizational success as we strive to become a global leader in immunology and autoimmune disease, while embodying our core values of Transparency, Relationships, Urgency, Excellence, and Innovation – the essence of TRUE Innovation!Position Summary:The Director of Regulatory Affairs will lead the daily regulatory activities of early and late-phase investigational products, steering the writing and submission of IND/CTA/amendments and future marketing applications. This role will provide essential guidance to the team on regulatory filings and responses while delivering critical regulatory intelligence back to the team. The Director will collaborate within a cross-functional team, partnering with key internal and external stakeholders, and work alongside Regulatory CMC, Medical Writing, and Regulatory Operations to ensure that scientific data and submissions meet agency expectations in a compliant manner. This position will report directly to the Executive Director of Global Regulatory Affairs.
Join AbbVie as an Associate Director in our CMC-Pharma Product Group, where you will play a pivotal role in leading cross-functional teams to drive the development and manufacturing of high-quality pharmaceutical products. Your expertise will be crucial in ensuring compliance with regulatory standards and enhancing our product portfolio.
Role Overview Sobi is hiring a US Regulatory Strategy Lead in Waltham. This role shapes regulatory strategies for the company’s therapies and works closely with teams across the organization. The position focuses on ensuring compliance and guiding products through approval processes. What You Will Do Develop and refine regulatory strategies for therapies in the US market Collaborate with cross-functional teams to support product submissions and approvals Help maintain compliance with relevant regulations throughout the development process Contribute to efforts that aim to improve patient outcomes through successful product launches
Join Sobi as the Director of Global Regulatory Advertising and Promotion, where you will lead the development and execution of regulatory strategies for advertising and promotional materials across global markets. Your expertise will ensure compliance with regulatory standards while driving innovative marketing initiatives that resonate with healthcare professionals and patients alike.
As the Director of Regulatory Advertising and Promotion for North America at Sobi, you will spearhead the strategic direction and oversight of all regulatory aspects related to advertising and promotional activities. This role is pivotal in ensuring compliance with all relevant regulations while promoting our innovative products within the market.
Sobi is seeking a Senior Medical Director of Rheumatology to join the Medical Affairs team in Waltham. This role centers on setting direction for rheumatology initiatives and collaborating with leading experts in the field. Key responsibilities Shape the medical strategy for rheumatology within Medical Affairs Guide research efforts to support new and ongoing projects Work closely with top professionals in rheumatology to advance patient care Impact The Senior Medical Director will play a central role in improving patient outcomes and supporting the development of new treatments in rheumatology. Location This position is based in Waltham.
Full-time|$183.2K/yr - $229K/yr|On-site|Waltham, MA
Zenas is a pioneering biopharmaceutical organization at the forefront of developing and commercializing innovative therapies for individuals suffering from autoimmune diseases. Our strategic approach integrates a seasoned leadership team with a focused acquisition strategy aimed at identifying and cultivating product candidates on a global scale, ensuring they deliver exceptional clinical benefits to patients. Currently, Zenas is advancing two promising late-stage molecules: obexelimab and orelabrutinib. Obexelimab, our flagship candidate, is a bifunctional monoclonal antibody tailored to bind both CD19 and FcγRIIb, effectively inhibiting the activity of B cell lineage cells implicated in various autoimmune conditions, all while sparing their depletion. We believe obexelimab’s unique mechanism of action and self-administered subcutaneous injection could significantly influence the treatment landscape of chronic autoimmune diseases. Orelabrutinib is a potentially leading, selective CNS-penetrant, oral Bruton’s Tyrosine Kinase (BTK) inhibitor, designed to tackle compartmentalized inflammation and disease progression in Multiple Sclerosis (MS). Our early-stage initiatives include groundbreaking preclinical candidates targeting IL-17AA/AF and TYK2.We invite driven professionals who share our passion for patient care and possess a proven track record in product acquisition, development, and commercialization on a global scale. At Zenas, team members are immersed in a dynamic learning environment, paving the way for both personal and organizational success as we strive to become leaders in immunology and autoimmune disease treatment, all while adhering to our core values of Transparency, Relationships, Urgency, Excellence, and TRUE Innovation!Position Summary:The Director of Advertising and Promotion will spearhead the regulatory strategy and oversight for Zenas’ product labeling and promotional activities. This role will establish the company’s expertise in FDA regulations, guidance, and enforcement trends regarding advertising, promotion, and labeling. The Director will ensure that all promotional and non-promotional materials comply with regulatory standards and will work collaboratively with cross-functional teams to support both developmental and commercial goals. This position reports directly to the Executive Director of Global Regulatory Affairs.
AbbVie is seeking a highly skilled and experienced Scientific Director or Medical Director to lead our Medical Affairs team specializing in Oncology, specifically focusing on Ovarian Solid Tumor. In this pivotal role, you will be responsible for driving strategic initiatives, providing medical insights, and collaborating with cross-functional teams to enhance patient outcomes through innovative therapies.
At Crescent Biopharma, we aspire to transform the landscape of oncology by developing cutting-edge therapies tailored for cancer patients. Our innovative pipeline includes a leading PD-1 x VEGF bispecific antibody, alongside state-of-the-art antibody-drug conjugates. By harnessing diverse therapeutic modalities and established targets, we aim to expedite the development of potentially groundbreaking treatments, whether as standalone interventions or in combination therapies targeting various solid tumors. For more insights into our mission and vision, visit our website and connect with us on LinkedIn and X.We are currently in search of an Associate Director or Director of Analytical & GMP Quality Assurance Operations. In this pivotal role, you will oversee and guide the QA functions related to analytical development, quality control operations, and GMP quality activities across our clinical-stage biologics and ADC programs. Collaboration with cross-functional teams, including CMC, Analytical Sciences, Quality Control, and Technical Operations, as well as external manufacturing and testing partners, will be key to ensuring compliance with phase-appropriate GMP standards, maintaining data integrity, and ensuring inspection readiness within a dynamic outsourced operational framework. Your strategic vision will be instrumental in shaping Crescent's analytical quality strategy and driving the disciplined execution of core quality systems that align with our aggressive development timelines.
As the Associate Director of Pharmacovigilance, you will play a crucial role in ensuring the safety and efficacy of our pharmaceutical products. You will lead a team dedicated to monitoring and evaluating adverse drug reactions, while also collaborating closely with regulatory bodies to uphold our commitment to patient safety. Your expertise will contribute significantly to our ongoing efforts in drug development and post-marketing surveillance. Join us in making a difference in the lives of patients around the world.
As the Associate Director of Access Strategy at Sobi, you will play a pivotal role in shaping the strategies that enhance patient access to our innovative therapies. This position requires a strategic thinker who is passionate about improving healthcare accessibility and is adept at navigating the complexities of the healthcare landscape. You will work closely with cross-functional teams to develop and implement access strategies that align with our organizational goals and promote patient-centric outcomes.
Deciphera Pharmaceuticals, Inc. is on the lookout for a seasoned Associate Director of Sales Operations to spearhead and enhance our field-facing operational strategies. This pivotal role will support the establishment of a high-performing Commercial field team, particularly focused on facilitating a successful brand launch. The successful candidate will ensure compliance, efficiency, and data-driven insights within field operations across our Hematology Franchise, playing a crucial role in ensuring operational readiness for product launches and ongoing excellence initiatives in the field.Key ResponsibilitiesFormulate and implement field operations strategies that align with both commercial and medical objectives.Manage field technology platforms including CRM systems, roster management, and reporting tools in collaboration with the IT department.Oversee territory design, roster management, and alignment processes to ensure compliance with coverage models.Coordinate onboarding operations with Training, HR, and Compliance teams.Direct the creation of field reports, dashboards, KPI tracking, and business insights.Ensure all field operations processes adhere to FDA, OIG, and corporate compliance standards.Lead continuous improvement initiatives aimed at enhancing scalability, efficiency, and quality.Collaborate effectively across functions including Sales, Marketing, Medical, Compliance, IT, HR, Legal, and Finance.
Full-time|$182K/yr - $208K/yr|Hybrid|Waltham, Massachusetts, United States
Oruka Therapeutics is developing biologics designed to change the treatment landscape for chronic skin conditions such as plaque psoriasis. The company focuses on long-lasting relief for patients, aiming for outcomes like disease clearance with infrequent dosing. Their pipeline includes proprietary antibodies created by Paragon Therapeutics, targeting the underlying causes of dermatologic and inflammatory diseases. More details about their work can be found at www.orukatx.com. Role overview The Associate Director of Clinical Operations will manage the setup and execution of clinical trials, supporting the Director of Clinical Operations within a specific therapeutic area. This position oversees multiple studies, combining strategic planning with day-to-day operational involvement to keep clinical programs on track and within budget. Responsibilities include handling operational details, anticipating challenges, and implementing solutions to ensure trial progress. The role requires someone who can move between leadership and hands-on work, maintaining a player/coach mindset throughout. What you will do Oversee all phases of clinical trial setup and execution across several studies Support the Director of Clinical Operations in a designated therapeutic area Balance strategic planning with direct, hands-on involvement in daily operations Identify and resolve operational challenges to maintain study timelines and budgets Requirements Demonstrated integrity and sound judgment in clinical operations Ability to shift between high-level oversight and direct involvement as needed Strong commitment to study goals and a collaborative approach Adaptability and resourcefulness in a biotech setting This hybrid role is based in Waltham, Massachusetts, with an expectation of three days onsite each week. The team values learning, growth, and a positive, inclusive culture.
Deciphera Pharmaceuticals is excited to invite applications for the role of Associate Director of Program Leadership & Management. In this pivotal position, you will provide exceptional leadership and strategic direction to our Development and Commercial Program Teams. Collaborating closely with the Program Lead, you will be instrumental in advancing programs from early to late-phase clinical development and lifecycle management. The ideal candidate will exhibit a comprehensive understanding of drug development, thrive in ambiguous situations, and possess outstanding communication skills to foster effective collaboration within program teams and across the organization.This role demands a high level of cross-functional teamwork, engaging with both internal and external partners. You will be responsible for leading daily program management activities, including the formulation and implementation of the program's Integrated Development Strategy. A deep understanding of overall program strategy and critical path activities, as well as risk identification and mitigation planning, is essential.Key ResponsibilitiesStrategic Partnership with the Program Lead (50%)Collaborate with the Program Lead to develop and execute strategic, integrated development plans through effective leadership of Program Teams.Provide clear guidance on product development requirements to align with the expectations of external customers and business stakeholders.Monitor program progress and related KPIs, identifying gaps and risks while offering strategic recommendations.Support the execution and ongoing reassessment of development strategies in line with the overall corporate strategy.Operational Excellence Across Program Teams (50%)Facilitate program team meetings to ensure productive and efficient discussions.Ensure timely and clear communication of program strategies and progress to relevant stakeholders.Coordinate the integration of sub-teams to enhance the effectiveness of Program Teams.
Full-time|$175K/yr - $200K/yr|Hybrid|Waltham, Massachusetts, United States
About Us:Oruka Therapeutics (Nasdaq: ORKA) is at the forefront of developing innovative biologics aimed at revolutionizing the treatment of chronic skin disorders. Our mission is to empower patients suffering from conditions such as plaque psoriasis by providing opportunities for significant disease clearance with minimal dosing frequency, potentially just once or twice a year. Leveraging a unique portfolio of advanced antibodies engineered by Paragon Therapeutics, we target the fundamental mechanisms contributing to plaque psoriasis and other dermatologic and inflammatory conditions. Learn more about our vision at www.orukatx.com.As we expand our core team, we are seeking passionate professionals who aspire to be part of a transformative journey, not just a job. If you are eager to make a positive impact and contribute to a vibrant, inclusive company culture, we want to hear from you.Job Title: Associate Director, Downstream, Manufacturing Sciences and Technology (Biologics)Location: Hybrid – Waltham, MA, with a requirement to be in-office 3 days a week.Position Overview:We are looking for a dynamic and skilled leader in Manufacturing Science and Technology (MSAT) to spearhead downstream late-stage and pivotal optimization, scale-up, and transfer of manufacturing processes. In this role, you will be responsible for process development, troubleshooting production challenges, data analysis, and ensuring adherence to regulatory standards to uphold product quality. The successful candidate will play a critical role in late-stage drug substance manufacturing and process validation activities to support BLA submissions. This position requires adaptability in a fast-paced environment, along with the ability to draft high-quality reports, finalize source documents, and actively participate in regulatory submissions. Join us as a vital member of a growing team dedicated to advancing best-in-class biotherapeutics.
